At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie)
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Participates on project teams, may lead small project(s), in the capacity of supporting application implementation, administration, and support
Evaluates and recommends process improvements and supports the development of processes required for the successful implementation of key software systems. Provide technical support for the management of data from multiple sources and databases for the eventual submission to multiple regulatory agencies
Interacts with Clinical and Regulatory departments on issues relating to electronic submissions
Leads evaluating and implementing additional technologies that may improve the overall quality of systems throughout all departments
Consults with department representatives to determine requirements for data access, reports, and interfaces
Maintains interaction with department managers to ensure successful implementation of data management/interface tools. This will include both regulatory and validation requirements for all Clinical/Regulatory data management projects
Other duties as assigned
BS/BA degree degree in computer science, IT, or similar field and 4+ years of IT experience working in a pharmaceutical company with exposure to FDA regulations. 5+ years of IT experience with the most recent experience in support of Microsoft applications utilizing the following technologies: MS SQL Server, Oracle, JAVA, Visual Basic, MS Access, MS Project, IIS, Internet Explorer, and Advanced Web technologies such as HTML, XML, SGML, Dynamic HTML, JavaScript, VBScript, and Internet Database Programming. Experience supporting validated applications for regulatory purposes in a biotech/pharmaceutical company strongly required OR
Master’s degree in computer science, IT, or similar field and 2+ years of similar experience noted above
PMP certification or working towards a certification is highly desired
Understands key business drivers and uses this understanding to accomplish work
Has strong understanding of processes, procedures and systems used to accomplish the work and recognizes downstream impact on other functional areas
Proficient with tools and processes that support work conducted by functional area
Ability to work as part of a team; may train lower levels
Possess excellent computer skills
Has strong communications, problem-solving, analytical thinking skills
Is detail oriented yet can see broader picture for department
Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
Has strong project management skills
Able to communicate technical information and work with all levels within the organization
Strong base knowledge of web application technology, electronic document management systems, electronic publishing systems for regulatory filings, and an in depth experience in database technologies and data warehousing/data mining
Strong knowledge of the most recent experience in support of Microsoft applications utilizing the following technologies: MS SQL Server, Oracle, JAVA, Visual Basic, MS Access, MS Project, IIS, Internet Explorer, and Advanced Web technologies such as HTML, XML, SGML, Dynamic HTML, JavaScript, VBScript, and Internet Database Programming
Strong knowledge of supporting validated applications for regulatory purposes in a biotech/pharmaceutical company strongly required
Neurocrine Biosciences is an EEO/Disability/Vets employer.
We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.